CoughNCT02591550
A Study on the Mechanism of Cough Hypersensitivity
An observational study of Cough, run by Kefang Lai at 1 site in China.
Trial summary
The aim of this study is described as follows, 1. To establish a validated method to test cough reflex sensitivity conducted by transient receptor potential vanilloid 1(TRPV1). 2. Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Chronic cough group:nonsmokers with chronic cough lasting ≥ 8 weeks characterized by irritating dry cough or small amount of sputum, sensitive to fumes，dust, cold air ,and normal chest x-ray were enrolled. Healthy control:healthy volunteers presented our hospital for healthy examination were enrolled.
Who may be able to join
- chronic cough group:
- cough lasting ≥ 8 weeks,characterized by irritating dry cough.
- sensitive to fumes，dust,the odorous and cold air.
- with normal chest x-rays. 4.17-70 years old.
- 5.without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result.
Who cannot join
- chronic cough group and healty controls group:
- with respiratory tract infection within 8 weeks.
- with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease.
- using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week.
- women during pregnancy or lactation.
- patients with malignant tumours.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 520120
Kefang Lai, PhD, 8620-83062893, klai@163.com
Kefang Lai, PHD
About this study
The aim of this study is described as follows,
- To establish a validated method to test cough reflex sensitivity conducted by transient receptor potential vanilloid 1(TRPV1).
- To observe the variance of cough reflex sensitivity conducted by transient receptor potential ankyrin 1(TRPA1) of chronic patients and the relationship between cough reflex sensitivity conducted by TRPA1 and conducted by TRPV1.
- To study the distribution of TRPA1 and TRPV1 channels and their relationship to cough reflex sensitivity.
Read the detailed description
This study is divided into two major part, Firstly,to observe the variance of cough reflex sensitivity of chronic cough patients and the relationship between it and airway inflammation.
- Recruit chronic cough patients and healthy volunteers as subjects.
- Help subjects to complete detailed history,physical examination,Hull airway reflux questionnaire,chest x-rays,induced sputum,blood routine test,pulmonary ventilation function test and histamine provocation test before they enter this study.
- Complete allyl isothiocynate(AITC) cough provocation test the day subjects enter the study,then complete capsaicin（CAP）cough provocation test after 3 days.
- To detect the substance P(SP),calcitonin gene-related peptide(CGRP),prostaglandin E2(PGE2),et al level in sputum supernatants.
Secondly,to observe the distribution of TRPA1,TRPV1 channels and the relationship between it and cough reflex sensitivity.
1）Recruit chronic cough patients and healthy volunteers and complete related examinations as mentioned before.
2)Collect mucosa specimens from upper trachea via endobronchial biopsy,and airway epithelial cells from 2nd or 3rd order bronchi via brushing.
3)Evaluate the expression level of TRPA1,TRPV1 of mucosa specimens of subjects by immunofluorescent assay and Image analysis software.
4)Cultivate airway epithelial cells from subjects and evaluate the expression of TRPV1,TRPA1 and functional changes of it.
- Conditions
- Cough
- Keywords
- chronic cough, cough reflex sensitivity, transient receptor potential vanilloid 1, transient receptor potential ankyrin 1
- Medical subject headings
- Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with normal cough sensitivity | Not described | |
| patients with high cough sensitivity | Not described | |
| healty controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRPA1,TRPV1 channels expression level of chronic cough patients and its relationship with cough reflex sensitivity
Complete AITC cough provocation test the day subjects enter the study,then complete CAP cough provocation test after 3 days,record the threshold of cap and aitc concentration(mmol/L) when it cause subjects cough equal to or more than 5 times.Measure the expression level of TRPA1 and TRPV1 of biopsy sample from chronic cough patients and healthy controls by immunofluoresent assay 7 days post bronchoscopy.Analyze the statistic by spss18.0.
Measured: 7 days post-bronchoscopy
Secondary outcomes (1)
The relationship between CAP cough reflex sensitivity test conducted by TRPV1 and AITC cough reflex sensitivity test conducted by TRPA1
Complete AITC cough provocation test the day subjects enter the study,then complete CAP cough provocation test after 3 days,record the threshold of cap and aitc concentration(mmol/L) when it cause subjects cough equal to or more than 5 times.Analyze the statistic by spss18.0.
Measured: 7 days post-bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kefang Lai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591550
- Sponsor's protocol ID
- coughlongli
- Status last verified
- Oct 2015
- First submitted
- 21 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lai K, Long L, Yi F, Tang J, Chen Z, Chen F, Zhou J, Peng W, Zhang L, Li H, Zhan W, Chen R, Luo W, Chen Q, Chung KF, Zhong N. Age and Sex Distribution of Chinese Chronic Cough Patients and Their Relationship With Capsaicin Cough Sensitivity. Allergy Asthma Immunol Res. 2019 Nov;11(6):871-884. doi: 10.4168/aair.2019.11.6.871.
PubMed 31552721Long L, Yao H, Tian J, Luo W, Yu X, Yi F, Chen Q, Xie J, Zhong N, Chung KF, Lai K. Heterogeneity of cough hypersensitivity mediated by TRPV1 and TRPA1 in patients with chronic refractory cough. Respir Res. 2019 Jun 6;20(1):112. doi: 10.1186/s12931-019-1077-z.
PubMed 31170994
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Mechanism of Cough Hypersensitivity
- ClinicalTrials.gov ID
- NCT02591550
- Acronym / sponsor ID
- coughlongli
- Conditions
- Cough
- Keywords
- chronic cough, cough reflex sensitivity, transient receptor potential vanilloid 1, transient receptor potential ankyrin 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kefang LaiUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is described as follows,
- To establish a validated method to test cough reflex sensitivity conducted by transient receptor potential vanilloid 1(TRPV1).
- To observe the variance of cough reflex sensitivity conducted by transient receptor potential ankyrin 1(TRPA1) of chronic patients and the relationship between cough reflex sensitivity conducted by TRPA1 and conducted by TRPV1.
- To study the distribution of TRPA1 and TRPV1 channels and their relationship to cough reflex sensitivity.
Detailed description
This study is divided into two major part, Firstly,to observe the variance of cough reflex sensitivity of chronic cough patients and the relationship between it and airway inflammation.
- Recruit chronic cough patients and healthy volunteers as subjects.
- Help subjects to complete detailed history,physical examination,Hull airway reflux questionnaire,chest x-rays,induced sputum,blood routine test,pulmonary ventilation function test and histamine provocation test before they enter this study.
- Complete allyl isothiocynate(AITC) cough provocation test the day subjects enter the study,then complete capsaicin（CAP）cough provocation test after 3 days.
- To detect the substance P(SP),calcitonin gene-related peptide(CGRP),prostaglandin E2(PGE2),et al level in sputum supernatants.
Secondly,to observe the distribution of TRPA1,TRPV1 channels and the relationship between it and cough reflex sensitivity.
1）Recruit chronic cough patients and healthy volunteers and complete related examinations as mentioned before.
2)Collect mucosa specimens from upper trachea via endobronchial biopsy,and airway epithelial cells from 2nd or 3rd order bronchi via brushing.
3)Evaluate the expression level of TRPA1,TRPV1 of mucosa specimens of subjects by immunofluorescent assay and Image analysis software.
4)Cultivate airway epithelial cells from subjects and evaluate the expression of TRPV1,TRPA1 and functional changes of it.
Study design
- Observational model
- Case-control
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with normal cough sensitivity | – | – |
| patients with high cough sensitivity | – | – |
| healty controls | – | – |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic cough group:nonsmokers with chronic cough lasting ≥ 8 weeks characterized by irritating dry cough or small amount of sputum, sensitive to fumes，dust, cold air ,and normal chest x-ray were enrolled. Healthy control:healthy volunteers presented our hospital for healthy examination were enrolled.
Key inclusion criteria (5 listed)
- cough lasting ≥ 8 weeks,characterized by irritating dry cough.
- sensitive to fumes，dust,the odorous and cold air.
- with normal chest x-rays. 4.17-70 years old.
- 5.without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result.
Key exclusion criteria (6 listed)
- with respiratory tract infection within 8 weeks.
- with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease.
- using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week.
- women during pregnancy or lactation.
- patients with malignant tumours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TRPA1,TRPV1 channels expression level of chronic cough patients and its relationship with cough reflex sensitivity
Time frame: 7 days post-bronchoscopy
Complete AITC cough provocation test the day subjects enter the study,then complete CAP cough provocation test after 3 days,record the threshold of cap and aitc concentration(mmol/L) when it cause subjects cough equal to or more than 5 times.Measure the expression level of TRPA1 and TRPV1 of biopsy sample from chronic cough patients and healthy controls by immunofluoresent assay 7 days post bronchoscopy.Analyze the statistic by spss18.0.
1 secondary outcome
The relationship between CAP cough reflex sensitivity test conducted by TRPV1 and AITC cough reflex sensitivity test conducted by TRPA1
Time frame: 7 days post-bronchoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Derived from this study: PubMed 31552721Lai K, Long L, Yi F, Tang J, Chen Z, Chen F, Zhou J, Peng W, Zhang L, Li H, Zhan W, Chen R, Luo W, Chen Q, Chung KF, Zhong N. Age and Sex Distribution of Chinese Chronic Cough Patients and Their Relationship With Capsaicin Cough Sensitivity. Allergy Asthma Immunol Res. 2019 Nov;11(6):871-884. doi: 10.4168/aair.2019.11.6.871.
- Derived from this study: PubMed 31170994Long L, Yao H, Tian J, Luo W, Yu X, Yi F, Chen Q, Xie J, Zhong N, Chung KF, Lai K. Heterogeneity of cough hypersensitivity mediated by TRPV1 and TRPA1 in patients with chronic refractory cough. Respir Res. 2019 Jun 6;20(1):112. doi: 10.1186/s12931-019-1077-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough, run by Kefang Lai at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kefang Lai, PhD (8620-83062893, klai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRPA1,TRPV1 channels expression level of chronic cough patients and its relationship with cough reflex sensitivity (time frame: 7 days post-bronchoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591550, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.